MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION DRAINS OASIS SINGLE; BOTTLE, COLLECTION, VACUUM

Model Number 3600-100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

Patient developed a bilateral pneumothorax pod 1 after coronary artery bypass surgery and was treated with bilat pigtail thoracostomies.Physician thought it may be tied to a defect in the atrium oasis dry suction water seal chest drain.In followup communication it was noted "when i clamped the tubes at the patient insertion sites there was no continued air leak noted.Secondly, i think that these pneumos where a result of her right subclavian central line as when this line was removed the air leak stopped.Currently she is on water-seal without respiratory distress.Patients currently in excellent condition.".

Event Description

N/a.

Manufacturer Narrative

Investigation: the customer reported that an 80 year old patient with breast cancer underwent a coronary artery bypass surgery and afterward developed a bilateral pneumothorax while connected to an oasis drain (p/n 3600-100).The report says the doctor wondered if a defect with the drain could be responsible, but does not allege any specific defect or malfunction.Follow-up questions were asked, including whether there was a specific malfunction the customer was concerned with and they answered there was not.The customer's answers indicated the drain was functioning properly.The customer did not provide pictures or a lot number and they indicated that the drain will not be returned.A medical assessment was completed for this complaint which states that pneumothorax is one of the most common complications with the type of procedure this patient had and it is an anticipated occurrence.It points out that because the air leak ceased when the patient's right subclavian central line was removed, that was likely the source of the leak.It concluded that the pneumothorax was likely due to multiple factors and the drain was not the sole contributing factor.A dhr review could not be completed because a lot number was not provided.A device finished good specification review was completed and no changes to the design were identified which are related to this complaint.The ifu provides adequate instructions for the setup and use of the device.No changes are needed to the ifu.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints.A review of crs/capas found none related to this complaint.Because the device was not returned and no images or any other evidence of the incident was provided, this complaint cannot be confirmed.A device nonconformity cannot be confirmed with the provided information or with the information reviewed in this investigation.No device nonconformance was alleged by the complaint and information provided by the customer about the patient's procedure indicated that the likely cause of the pneumothorax was another device, as discussed in the medical assessment.The medical assessment also discusses that a pneumothorax is a common and anticipated occurrence with this type of procedure, particularly with a frail patient.The root-cause of this complaint is user - anticipated procedural complication.H3 other text: device not available for return.

• Brand Name: DRAINS OASIS SINGLE
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 16716890
• MDR Text Key: 313065089
• Report Number: 3011175548-2023-00099
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 54 KG